What is Psychological Support in the Context of Psychedelic Clinical Trials?

Psychological support in psychedelic clinical trials is poorly defined, with little agreement on its essential components, boundaries, or limits. This perspective article proposes using the microskills framework from Ivey et al. (2021) to distinguish psychological support from psychotherapy by focusing on specific communication units and behaviors. The authors argue that trial protocols and treatment manuals should clearly define which psychosocial interventions and behaviors are permitted, to prevent interventions that exceed the trial's mandate or the session monitor's regulatory scope of practice.

Study at a glance

Abstract

The topic of psychological support and psychotherapy in the context of clinical investigations of psychedelic drugs is an often debated, yet predominantly unresolved issue in the field. Psychological support, as a concept, is poorly defined and there appears to be little agreement in the field regarding its essential components, boundaries and limits. While researchers have turned their attention to the role of placebo conditions and expectancy effects within the context of psychedelic clinical trials, the nature and role of psychological support remains difficult to define and capture. The objective of this perspective article is to provide a concrete description of the specific components, boundaries and limits of psychological support in comparison to psychotherapy based on the microskills framework established by Ivey et al. (2021). We propose that greater attention be placed on the specific communication units and behaviors that are considered psychological support or psychotherapy in the context of psychedelic clinical trials. Clinical trial protocols and treatment manuals should clearly define the psychosocial interventions and behaviors that fall within and outside of the scope of the trial to eliminate interventions that are not within the mandate of the specific trial or exceed the regulatory scope of practice of the session monitor(s).